FDA.reportPublic FDA data

QUALITY CHOICE HEMORRHOIDAL

Product NDC
63868-951
11-digit product format
638680951
Labeler code
63868
Product ID
63868-951_49aae62f-d4e8-4470-8600-da4df73aa5ac
Type
HUMAN OTC DRUG
Nonproprietary name
MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL, SHARK LIVER OIL
Dosage form
OINTMENT
Route
TOPICAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION INC
Application
part346
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-03-01
Marketing end
0000-00-00
Substance
MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL
Active strength
140 mg/g; mg/g; mg/g; mg/g
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-951-572019-11-13C16284748780-197449f38-d526-f6ea-e053-dbdaa90aa703Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-951-57QUALITY CHOICE HEMORRHOIDAL1 in 1 CARTONOINTMENT11
63868-951-57QUALITY CHOICE HEMORRHOIDAL57 g in 1 TUBEOINTMENT571

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MINERAL OILACTIVE INGREDIENTT5L8T28FGPQUALITY CHOICE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL, SHARK LIVER OIL) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC]1
PETROLATUMACTIVE INGREDIENT4T6H12BN9UQUALITY CHOICE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL, SHARK LIVER OIL) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJQUALITY CHOICE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL, SHARK LIVER OIL) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC]1
SHARK LIVER OILACTIVE INGREDIENT4B24275HEUQUALITY CHOICE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL, SHARK LIVER OIL) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC]1
MINERAL OILACTIVE MOIETYT5L8T28FGPQUALITY CHOICE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL, SHARK LIVER OIL) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC]1
PETROLATUMACTIVE MOIETY4T6H12BN9UQUALITY CHOICE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL, SHARK LIVER OIL) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVQUALITY CHOICE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL, SHARK LIVER OIL) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC]1
SHARK LIVER OILACTIVE MOIETY4B24275HEUQUALITY CHOICE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL, SHARK LIVER OIL) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMQUALITY CHOICE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL, SHARK LIVER OIL) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UQUALITY CHOICE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL, SHARK LIVER OIL) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KQUALITY CHOICE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL, SHARK LIVER OIL) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TQUALITY CHOICE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL, SHARK LIVER OIL) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC]1
PARAFFININACTIVE INGREDIENTI9O0E3H2ZEQUALITY CHOICE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL, SHARK LIVER OIL) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHQUALITY CHOICE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL, SHARK LIVER OIL) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC]1
THYME OILINACTIVE INGREDIENT2UK410MY6BQUALITY CHOICE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL, SHARK LIVER OIL) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC]1
WATERINACTIVE INGREDIENT059QF0KO0RQUALITY CHOICE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL, SHARK LIVER OIL) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-951QUALITY CHOICE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL, SHARK LIVER OIL) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC]1Legacy NDC, 2 package rows20120315_8db1cff7-337f-4ed3-a4de-2d392eb908c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1544968mineral oil 14 % / petrolatum 71.9 % / phenylephrine HCl 0.25 % / shark liver oil preparation 3 % Rectal OintmentPSN8db1cff7-337f-4ed3-a4de-2d392eb908c61
1544968mineral oil 0.14 MG/MG / petrolatum 0.719 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG / shark liver oil 0.03 MG/MG Rectal OintmentSCD8db1cff7-337f-4ed3-a4de-2d392eb908c61
1544968mineral oil 14 % / petrolatum 71.9 % / phenylephrine HCl 0.25 % / shark liver oil preparation 3 % Rectal OintmentSY8db1cff7-337f-4ed3-a4de-2d392eb908c61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63868-951-57638680951571 in 1 CARTONHistorical